Usual Adult Dose for:

Usual Geriatric Dose for:

Additional dosage information:

Usual Adult Dose for Pain

Usual dose: 2 tablets every 4 to 6 hours as needed for pain
Maximum dose: 8 tablets per day
Maximum duration: 5 days

Comments:
-Each tablet contains Tramadol 37.5 mg and Acetaminophen 325 mg. Maximum daily doses are Tramadol: 300 mg per day and Acetaminophen 2600 mg per day.
-Use of more than 1 product at time containing acetaminophen is not recommended.

Use: For the short-term management of acute pain; use should be limited to 5 days or less.

Usual Geriatric Dose for Pain

Dose selection should be cautious due to potential for greater sensitivity to adverse events.

Renal Dose Adjustments

Liver Dose Adjustments

Use is not recommended.

Precautions

US BOXED WARNING: HEPATOTOXICITY
-Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg per day, and often involve more than 1 acetaminophen-containing product.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Patients may receive their regular dose of acetaminophen-tramadol on the day of dialysis since less than 7% of tramadol is removed by hemodialysis.

Other Comments

Administration advice:
-May be taken with or without food

General:
-Seizures and/serotonin syndrome may occur when used concomitantly with serotonergic agents (SSRIs, SNRIs, and triptans) or with drugs that significantly reduce the metabolic clearance of tramadol.
-Taking this drug in excessive doses, either alone or in combination with other CNS depressants, including alcohol, is a major cause of drug-related deaths.
-This drug should not be used for longer than therapeutically necessary; evaluate continued use at regular intervals.

Monitoring:
-Monitor regularly for the development of addiction, abuse, and misuse.

Patient advice:
-Patients should be instructed not to exceed the recommended dose or take this product with any other product that contains acetaminophen without first speaking with their healthcare provider; if a patient takes more than 4,000 mg of acetaminophen in a day, they should be instructed to seek medical advice, even if they feel fine.
-Patients should avoid alcohol while taking this product.
-Patients should understand the risks of life-threatening respiratory depression, and be informed as to when this risk is greatest.
-This drug may cause drowsiness, dizziness, or impair thinking or motor skills; patients should avoid driving or operating machinery until adverse effects are determined.
-Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.
-Women of child bearing potential should understand that prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome and that prompt recognition and treatment will be necessary.